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 An authorization for that age group would be would be an important
regulatory step toward reaching about 28 million children for
inoculation, most of them back in school for in-person learning.
The vaccine could be available to the younger age group as soon as
next week. The FDA is not obligated to follow the advice of its
outside experts, but usually does. The vote was 17 in favor with one
abstention.
If the FDA authorizes the shots for this age group, an advisory
panel to the U.S. Centers for Disease Control and Prevention will
meet next week to make a recommendation on the administration of the
vaccine. The CDC director will make the final call.
While children becoming seriously ill or dying from COVID-19 is
relatively rare compared with adults, some develop complications,
and infections in unvaccinated kids have risen due to the easily
transmitted Delta variant of the coronavirus. Data from the American
Academy of Pediatrics shows that more than 500 U.S. children have
died from COVID-19.
It "is the eighth highest killer of kids in this age group over the
past year," said Dr. Amanda Cohn, a pediatric vaccine expert at the
CDC and a voting member of the panel. "Use of this vaccine will
prevent deaths, will prevent ICU admissions and will prevent
significant long-term adverse outcomes in children."
Only a few other countries, including China, Cuba and the United
Arab Emirates, have so far cleared COVID-19 vaccines for children in
this age group and younger.
In the United States, just 57% of the population is fully
vaccinated, lagging other nations such as the UK and France.
Still, the percentage of young children who receive the shots may be
low. The U.S. vaccination rate for 12- to 15-year-olds trails other
age groups at roughly 47%.
The World Health Organization since May has been urging rich
countries to reconsider plans to vaccinate children and instead
donate COVID-19 shots to the COVAX program for distribution to
poorer countries.
LOWER DOSE
Pfizer and BioNTech are seeking clearance for a lower, 10-microgram
dose of the vaccine in young children, versus 30 micrograms for
those age 12 and older. The shot has been authorized for ages 12-15
since May after being cleared for those age 16 and older in
December.
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The companies have said their vaccine showed 90.7% efficacy against
the coronavirus in a clinical trial of children aged 5 to 11.
The advisers paid close attention to the rate of a heart
inflammation called myocarditis that has been linked to both the
Pfizer/BioNTech and Moderna vaccines, particularly in young men.
If the number of myocarditis cases in the younger age group turns
out to be similar to that in 12- to 15-year-olds, the
hospitalizations prevented for COVID-19 would outnumber those
prevented for myocarditis in most scenarios analyzed, FDA staff
reviewers said in documents prepared ahead of Tuesday's meeting.
Some panel members suggested that due to the myocarditis risk, the
vaccine should be given to a narrower group of children, such as
those with conditions that make them more likely to be hospitalized.
"There are certain kids that should be vaccinated. The question of
how broadly to use it, I think it's a substantial one," said Eric
Rubin, Editor-in-Chief of the New England Journal of Medicine.
If authorized, the Pfizer/BioNTech vaccine is likely to be the only
one available to the age group in the United States for some time.
On Monday, Moderna released data from its own clinical trial of
children ages 6 to 11, and said it would soon ask regulators for
authorization in the age group.
It is unclear when U.S. regulators will consider that. The company
is still waiting for a response to its application filed in June for
use of its vaccine in children ages 12 through 17.
Pfizer has said it could have data from its clinical trial in even
younger children - ages 2 to 4 - by year end.
(Reporting by Manas Mishra in Bengaluru, Michael Erman in New Jersey
and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill
Berkrot)
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